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NCT Number: NCT00823628

Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

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Key information

Conditions

Chronic Renal Insufficiency Chronic Disease Coronary Angiography Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who undergo coronary catheterization
  • creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

Exclusion criteria

  • pregnancy or lactation
  • having received contrast media within 7 days of study entry
  • emergent coronary angiography
  • acute renal failure or end-stage renal disease requiring dialysis
  • history of hypersensitivity reaction to contrast media
  • unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
  • multiple myeloma
  • parenteral use of diuretics
  • use of N-acetylcysteine
  • use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure

Treatment and study plan

contrast agent (iopromide)

Drug

coronary angiography using the allocated contrast agent

contrast agent (iodixanol)

Drug

coronary angiography using the allocated contrast agent

Primary outcomes

  1. Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)

    Time frame: days 1 and 2

Secondary outcomes

  1. proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine

    Time frame: days 1 and 2

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 15, 2009
Registry last updated
Jul 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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